Tissue suturing device using rotating needles

ABSTRACT

A medical device for installing sutures to close an incision in tissue or human skin is disclosed. The suturing device may provide first and second arcuate needles. Once properly positioned, the first and second arcuate needles are driven through the sub-dermal layer, or alternatively through a superficial surface, of two sections of skin to be joined. This is done in arcuate fashion and at identical and symmetrical rates of angular displacement. In so doing, the sections of skin are pushed toward one another thus assuring horizontal and vertical alignment of the two sections of skin. During the driving or retraction process of the first and second arcuate needles, a suture is positioned within both the first and second sections of skin and transformed from a planar or a multi-planar serpentine orientation to a helical orientation. The resulting suturing process is thus much faster than conventional or manual suturing and results in superior wound approximation/alignment that will lead to decreased scarring compared to prior art devices.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. non-provisional patentapplication Ser. No. 13/332,720, filed on Dec. 21, 2011, which in turnclaims the benefit of U.S. Provisional Application Ser. No. 61/427,003,filed on Dec. 23, 2010.

FIELD OF THE DISCLOSURE

The present disclosure generally relates to medical devices, and moreparticularly relates to medical devices for suturing skin.

BACKGROUND OF THE DISCLOSURE

The closure of incisions or lacerations in human skin has long been aneed in the medical industry. Whether the incision is the result ofsurgeries such as cosmetic surgery or internal organ operations, orthose generated by traumatic events or accidents, surgeons arecontinually presented with patients needing closure of such skinopenings. For example, modern studies indicate that approximately 30million such operations are performed each year in the U.S. alone.

In closing such incisions, surgeons are able to choose from a relativelylimited number of options currently available. One of those options ismanual suturing. This is perhaps the oldest of the available options andconventionally involves the physician directing a needle, to which istemporarily attached a suturing filament, through one section of skin,across the incision and into the other side of the incision. Thisprocess is repeated as many times as necessary to result in a certainnumber of “stitches” closing the incision. Upon reaching the end of theincision, the physician ties off the last suture to complete theprocess. While effective, manual suturing is certainly not without itsdrawbacks. For example, in the case of body contouring surgery,relatively large incisions in excess of many centimeters may be madewhich can often take the surgeon a very long time to close. It is notuncommon for the suturing of the incision to take longer than the actualoperation itself. Not only is it time consuming, but surgeons often viewthe process as tedious. Moreover, the repeated movement of the needlethrough the skin of the patient necessarily increases the risk to thesurgeon or assistant of being exposed to a needle prick which in turncan lead to certain transmissions of diseases including but not limitedto Hepatitis C and HIV.

Given the time and difficulty involved with manual suturing, anotherclosure option which is commonly employed is referred to as stapling.This process typically uses metal staples that are reminiscent of thestaples commonly used in office settings to clip papers together.Specifically, stapling involves directing first and second parallelprongs of the staple into the first and second sections of skin to beconnected, and against an anvil-like surface provided on the outside ofthe incision. When the prongs penetrate through the skin and contact theanvil, the prongs are deformed so as to be transverse to the main bodyof the staple and thus secured in position. The prongs are typicallycanted slightly inwardly so as to facilitate this deformation. Thestaples are installed using a medical device typically having some formof spring biased drive mechanism to quickly and effectively deploy thestaples.

While significantly faster than manual suturing, staples themselves arealso associated with certain drawbacks. Foremost among those drawbacksis the significant scarring associated with staples. The scarring isoften referred to as “railroad tracks”, as the scar will typicallyinclude the linear incision itself laterally flanked by pairs ofmatching demarcations where the prongs of the staple enter the skin.Moreover, staples are significantly more painful to the patient in thatthey need to be removed after being installed and after the incision ishealed. Suturing, on the other hand, can often be performed withabsorbable sutures which disintegrate or are absorbed by the body afterinstallation.

In light of the foregoing, a still further option currently available tosurgeons is known as an absorbable dermal stapler wherein the staplesare manufactured from a material or anchor which can be absorbed by thepatient. One example of such an absorbable dermal stapler is marketedunder the trademark “Insorb™”. This can potentially avoid a significantlevel of pain associated with metal staple removal, but may result insignificant scarring or poor wound healing in general. This is due to:(a) less than optimal alignment associated with such absorbable staplersbetween the two sections of skin to be fastened; (b) poor wound holdingstrength which can result in areas of wound separation if there is anytension on the wound edges (tension which is not uncommon during thepost-operative period) and; (c) and creation of small areas of woundseparation where the thick fasteners extrude through the incision (knownclinically as “spitting” of the fasteners). In order to most effectivelyclose an incision with minimal scarring, it is advantageous to positionthe first and second sections of skin so as to both be within the sameplane (vertical alignment), and to approximate the skin edges as closetogether as possible (horizontal alignment). If these sections of skinare not well approximated with regard to horizontal alignment, theresulting scar will be relatively wide as the body will fill in the gapwith additional connective tissue. If the wound edges are not wellaligned in the vertical dimension, then the scar will heal with a“step-off” which causes the scar to be more prominent.

Current absorbable dermal stapling technology provides less than optimalhorizontal and vertical alignment. In addition to ensuring precisealignment of the superficial skin surface (epidermis), optimal woundclosures should provide good approximation and support in the deeperstrength-bearing layer of the skin (dermis). When the dermis iseffectively secured, the wound forms a wound surface that is wellaligned but slightly protrusive at the superficial surface, a desirablewound configuration that is clinically known as “eversion.” As the woundheals, the eversion gradually settles, resulting in a flat/optimal scar.The converse of eversion is wound inversion, which is characterized bythe closed wound edges dipping inward. Inversion must be avoided inorder to prevent the wound from forming a scar with a recessed valleyappearance. Current dermal staplers attempt to position the wound in aneverted fashion. However, the method in which the fasteners hold thewound edges in eversion results in prominent “dimpling” of the skinwhere the fasteners secure the skin edges, a closure appearance whichcan cause concern to surgeons when they try dermal staplers for woundclosure.

With all these drawbacks in mind, a most recent effort has been made toprovide a medical device which provides the fast and efficient closureafforded by staplers, with the decreased scarring associated withsuturing. For example, U.S. Publication No. 2009/0093824 discloses awound closure device which is adapted to position an anchor specificallyknown as an “H-Type” fastener between first and second sections of skinto be secured. The device includes channels in which the first andsecond sections of skin are to be positioned and includes a singlearcuately shaped rotating needle adapted to enter one section of skinthrough the sub-dermal layer and carry the H-shaped anchor therewith.While the '824 application attempts to position the first and secondsections of skin relative to one another, the use of such an H-shapedanchor does not adequately pull the two sections close together afterinsertion and thus would result in longer healing times and morescarring than is acceptable. More specifically, the leading prong of the“H” needs to be pulled entirely through the second section of skin inorder to deploy. Once it is so deployed and released, the anchor ispulled back by the opposite prong and the normal tension on the woundedges, thus resulting in slack in the anchor and a loose “seam”.Moreover, the '824 application uses a complex system of rotatingapproximation arms to push the first and second sections of skin towardone another prior to insertion of the anchor. Not only does this makethe device more complicated and expensive to manufacture and prone toreliability problems, but once the approximation arms are retracted sotoo are the sections of skin and again the resulting closure does notensure optimal alignment, which would lead to prominent or otherwisepoor scarring.

SUMMARY OF THE DISCLOSURE

In accordance with one aspect of the disclosure, a suturing device isdisclosed. The suturing device may comprise a first arcuate needleadapted to rotate in a first direction through a dermal layer of a firstsection of skin to be sutured and through the dermal layer of a secondsection of skin to be sutured, a second arcuate needle adapted to rotatein a second direction opposite to the first rotational direction andthrough a dermal layer of a second section of skin to be sutured andthrough the dermal layer of the first section of skin to be sutured, anda drive mechanism forcing rotation of the first and second arcuateneedles upon activation by a user and adapted to insert a suturedetachably attached to the first and second arcuate needles.

In accordance with another aspect of the disclosure, a method ofsuturing skin is disclosed. The method may position a suturing deviceproximate first and second sections of skin to be sutured together,drive first and second arcuate needles in opposing directions ofrotation into the first and second sections of skin, and deploy a sutureconnecting the first and second sections of skin upon movement of thefirst and second needles. The first and second needles may separatelyenter dermal layers of the first and second sections of skin.

In accordance with yet another aspect of the disclosure, a tissue sutureis disclosed. The tissue suture may comprise an elongated filamenthaving first and second ends, a first needle guide positioned at thefirst filament end, and a second guide surface positioned at the secondfilament end. The filament may have a pre-insertion orientation and apost-insertion orientation. The pre-insertion orientation may be withinat least one plane, and the post-insertion orientation may be helical.

These and other aspects and features of the disclosure will be betterunderstood upon reading the following detailed description when takeninto conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a suturing tool constructed inaccordance with the teachings of the disclosure;

FIG. 2 is an enlarged perspective view of the suturing tool of FIG. 1;

FIG. 3. is a side view of the suturing tool of FIG. 1;

FIG. 4 is a perspective view of the suturing tool of FIG. 1, withcertain portions of its exterior cut-away to reveal the drive mechanismof the tool;

FIG. 5 is an enlarged perspective view of the drive mechanism of FIG. 5;

FIG. 6 is an enlarged perspective view of the drive mechanism of FIG. 5,shown from the opposite side of FIG. 5;

FIG. 7 is an enlarged front view of the operating end of the suturingtool of FIG. 1;

FIG. 8 is a cartridge constructed in accordance with one embodiment ofthe present disclosure and used in conjunction with the suturing tool ofFIG. 1;

FIGS. 9A-9B are enlarged plan views of suturing needles constructed inaccordance with the teachings of the disclosure;

FIGS. 10A-10I are schematic views of slider plates configured to secureengagement between the needles and sutures;

FIGS. 11A-11J are perspective views of multiple embodiments of suturesconstructed in accordance with the teachings of the disclosure;

FIGS. 12A-12B are schematic views of a suture pre-insertion andpost-insertion depicting how outwardly extending elements of the sutureavoid medialization and retraction;

FIG. 13 is a perspective view of a test fixture version of the suturingdevice in actual use and shown in an engaged position;

FIG. 14 is a bottom perspective view of the test fixture version ofsuturing device of FIG. 13;

FIGS. 15A-15E depict plan views of an incision at various stages afterthe suturing tool of the present disclosure has been used;

FIGS. 16A-16F are schematic representations of the suture pre-insertionwhen the closed helix configuration of the technology is used;

FIG. 16G is a schematic representation of the suture post-insertion asviewed from the deep skin surface when the closed helix configuration ofthe technology is used;

FIGS. 16H-16M are schematic representations of the suture pre-insertionwhen the open helix configuration of the technology is used;

FIG. 16N is a schematic representation of an oblique view of the suturepost-insertion as viewed from the superficial skin surface when the openhelix configuration of the technology is used;

FIG. 17 is a perspective view (from the bottom/sub-dermal/undersurface)of the skin sections sutured together in open helix configuration inaccordance with the teachings of the disclosure;

FIG. 18 is a plan view of two other sections of skin after being suturedby the present disclosure and showing the specific shape and position ofmultiple sutures after insertion in open helix configuration;

FIG. 19 is a perspective view of the superficial/exterior skin surfaceof FIG. 17;

FIGS. 20A-20C are perspective views of prior art closure devices incomparison to the closure device of the present disclosure.

FIG. 21 is a perspective view of an alternative embodiment of a suturingtool constructed in accordance with the teachings of the disclosure andadapted to interface with the epidermal layer of skin, wherein thesuture and cartridge (e.g., the alternate version of FIG. 8) have beenremoved for illustration purposes;

FIG. 22 is an enlarged perspective view of the operating end of thesuturing tool depicted in FIG. 21;

FIG. 23 is an end view of the operating end of FIG. 21 and depicting theinsertion needles in a pre-insertion position;

FIG. 24 is an end view similar to FIG. 23 but showing the needles in anengaged position;

FIG. 25 is a side view of a portion of the drive mechanism and operatingend of the suturing tool of FIG. 21;

FIG. 26 is a front perspective view of the drive mechanism and operatingend of FIG. 25;

FIG. 27 is a bottom perspective view of the drive mechanism andoperating end of FIG. 25;

FIG. 28 is a longitudinal cross-sectional view of a test version of adrive mechanism and drive shafts showing the coaxial disposition of thedrive shafts for the first and second needles;

FIG. 29 is a perspective view of a laparoscopic embodiment of a suturingtool constructed in accordance with the disclosure;

FIG. 30 is an enlarged perspective view of the operating end of thelaparoscopic embodiment of FIG. 29, with the needles shown in retractedpositions; and

FIG. 31 is an enlarged perspective view of the operating end of thelaparoscopic embodiment with the needles shown in extended positions.

While the present disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments thereof havebeen shown in the drawings and will be described below in detail. Itshould be understood, however, that there is no intention to limit thepresent invention to the specific forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructionsand equivalents falling within the spirit and scope of the presentdisclosure.

DETAILED DESCRIPTION

Referring now to the drawings, and with specific reference to FIG. 1, asuturing device constructed in accordance with the teachings of thepresent disclosure is generally referred to by reference numeral 20. Thedevice, as will be described in further detail herein, is advantageousfor surgically closing incisions, not only quickly, but with closelyapproximated edges and minimal scarring. Of course, the suturing device20 can also be used to close lacerations from traumatic events such asaccidents, or the like. The first embodiment of FIGS. 1-9 of thesuturing tool 20 is designed to be placed under the skin sections of theskin to be sutured, and then place a suture into the dermal layers ofthe skin. In later described embodiments, suturing tools are describedto be used against the epidermal layer of the skin, from the outer skinsurface, or be used laparoscopically. Although the embodiments disclosedherein demonstrate suturing as applied to skin, it will be understoodthat the present disclosure may be equally or similarly applied totissues other than skin.

Again referring to FIG. 1, it will be noted that the suturing device 20includes a grip 22 consisting of a handle 24 and a trigger 26.Compression of the trigger 26 toward the handle 24 by the hand of thesurgeon causes a drive mechanism 28 to move the internal components ofan operating end 30 and thereby install a suture 32 into the dermallayers of skin of a patient (not shown in FIG. 1, but shown laterherein).

More specifically, the operating end 30 is shown in further detail inFIGS. 2-7. As will be noted herein, the operating end 30 includes afirst arcuate needle 34 and a second arcuate needle 36 adapted to rotateabout a common axis 37 as will be described in further detail herein.The motion begins upon compression of the trigger 26 toward the handle24 which causes a lever arm 39 to rotate about a pivot 40 to thus causea rack 41 to rearwardly retract. This in turn causes a pinion 42connected to the drive axle 43, and rotatably journalled in plate 44, torotate. As shown, the drive axle 43 terminates in a first bevel gear 45which meshes with second and third bevel gears 46, 47 positioned atright angles relative to the first bevel gear 45. Rotation of the secondand third bevel gears 46, 47 causes first and second needles 34, 36 torotate due to coaxial drive shafts 48, 49 being positioned therebetween.As will be noted, drive shaft 48 is hollow to allow drive shaft 49 to berotatable therein. Other mechanical and electrical transmissions andgear arrangements, including motorized drive mechanisms, are certainlypossible and encompassed within the scope of this disclosure.

FIGS. 4-7 further depict the rotational characteristics of the first andsecond arcuate needles 34, 36. In an initial or resting position priorto insertion of the suture 32, the first and second arcuate needles 34,36 are retracted within the operating end 30. Upon compression of thetrigger 26 toward the handle 24, the first and second arcuate needles34, 36 are caused to rotate. By way of example, the needles 34, 36 couldrotate approximately 180-270 degrees, but the exact angle may depend onthe specific fastener configuration used. In so doing, the first andsecond arcuate needles 34, 36 are driven through the first and secondsections of skin, respectively. Moreover, as will be described infurther detail herein, such rotational motion of the first and secondarcuate needles 34, 36 can cause the suture 32 to be driven or pulledthrough the first and second sections of skin, respectively.

FIGS. 4-7 depict the drive mechanism 28 in greater detail. As shown, theoperating end 30 includes first and second guide channels 50, 52 adaptedto receive first and second sections of skin to be sutured. In addition,the operating end 30 further includes a septum blade 54 therebetween. Byproviding such an arrangement, where two arcuate needles 34, 36 arerotated toward one another relative to guides 50, 52 and a septum blade54, the portions of skin being connected are forced toward each otherupon activation. This in turn assists in vertically and horizontallyaligning the sections of skin and forming a tightly grouped closure.

While the method of suturing will be described in further detail herein,the structure of the suture 32 will first be described with respect toFIG. 8. As shown herein, in one embodiment the suture 32 may include anelongated filament 56 having first and second ends 58, 60. Each of thefirst and second ends 58, 60 may terminate with a needle guide 62 tofacilitate temporary attachment and release of the suture 32 to one ofthe first and second arcuate needles 34, 36, respectively. For example,the needle guide 62 may simply be an enlarged diameter aperture 64 whichis shaped so as to circumnavigate a terminus 66 of either the first orsecond arcuate needles 34, 36. The sutures 32 may each be providedwithin a cartridge 68 as shown in FIGS. 5-8. Moreover, the suture 32 maybe temporarily held in the cartridge 68 by frangible connections 70connecting the suture 32 to a cartridge frame 71 which are broken whenneedles 34, 36 penetrate or pull termini 66. In alternativemodifications, the suture 32 may also be temporarily held in thecartridge 68 by guide channels, grooves, recesses, apertures, or thelike.

Additionally, the cartridge frame 71 may include a plurality ofserrations 75 to facilitate holding the skin without the need forrestraining jaws, or the like. The frame 71 may also include angled sidebeams 81 for mounting the serrations 75. In so doing, first and secondsections of skin (not shown) are held between the angled side beams 81,the guide channels 50, 52, and the septum blade 54 in the aforementioned“everted” position to most effectively form a skin closure with minimalscarring. Furthermore, the cartridge 68 may be configured to be whollyreplaceable such that, for instance, a new cartridge 68 may be loadedonto the operating end 30 before each suturing operation. Alternatively,the cartridge 68 may be permanently disposed within the suturing device20 and configured to receive replaceable sets of sutures 32 before eachsuturing operation.

As shown in FIGS. 9A-9B, the needles 34, 36 of the suturing device 20,may include tips 72 having recesses 74 to facilitate engagement andremoval of the suture 32 from the cartridge 68. In particular, forretrograde applications, where the needle guides 62 are pulled throughthe skin, the recess 74 of each needle 34, 36 may be outwardlyconfigured to engage the respective needle guide 62 while exiting theskin, for example, upon release of the suturing device 20.Alternatively, for antegrade applications, where the needle guides 62are driven into the skin, the recess 74 of each needle 34, 36 may beinwardly configured to engage the respective needle guide 62 whileentering the skin, for example, upon engagement of the suturing device20. In still further modifications, the recess 74 may be disposed alongthe outer surface of the needle 34, 36 rather than the inner surface asshown in FIGS. 9A-9B.

In order to secure the engagement between the suture 32 and the needle34, 36 during deployment, slider plates 73 as shown in FIGS. 10A-10I, orthe like, may be provided to temporarily hold and align each needleguide 62 along the rotational path of its corresponding needle 34, 36.Moreover, in the retrograde configuration of FIGS. 10A-10I, the sliderplates 73 may be configured to enable the needles 34, 36 to pass throughthe needle guides 62 upon actuation of the suturing device 20 andsecurely seat the needle guides 62 in the corresponding recesses 74 ofthe needles 34, 36 upon release of the suturing device 20 and prior todeployment of the suture 32. As shown in FIGS. 10A-10B, the sliderplates 73 may be slidably disposed within the cartridge 68 and shaped toreceive the needle guide 62 of a suture 32 therein. As shown in FIG.10C, each slider plate 73 may provide grooves 77 within which the needleguides 62 of the suture 32 are seated. While the embodiments of FIGS.10A-10I are shown with looped needle guides 62, it should be understoodthat the slider plates 73 may be adapted to receive other needle guidedesigns as well.

The slider plates 73 may also be slidable relative to the cartridge 68so as to enable the slider plates 73 to move in accordance with therotation of the needles 34, 36. Additionally, as further disclosed inFIG. 10D, the slider plate 73 may include a recess 83 which slidablymates with the cartridge 68 to house a biasing mechanism. Moreover, thebiasing mechanism may employ a spring, or the like, configured to biasthe slider plates 73 in a substantially medial position, a lateralposition, or any combination thereof, relative to the cartridge 68. Theslider plates 73 may further comprise a cam slot 85 having surfaceswhich interface with the inner and/or outer edges of each needle 34, 36,and more particularly, with the needle tip 72 thereof. Morespecifically, the surfaces of the cam slot 85 may be sized, angled, andgenerally configured to abut the edges of each needle tip 72 as theneedles 34, 36 are advanced therethrough and to secure engagementbetween the recesses 74 of the needles 34, 36 and the correspondingneedle guides 62.

As shown in the retrograde application of FIGS. 10E-10F, for example,when the suturing device 20 is engaged and the needles 34, 36 areadvanced, the outer edge of each needle tip 72 may push against theinwardly facing surfaces of the cam slots 85, causing the slider plates73 to slide outwardly relative to the needles 34, 36 and the cartridge68. Such outward motion of the slider plates 73 may be limited by theabutment between the outwardly facing surface of the clam slots 85 andthe inner edge of the needles 34, 36, as shown for example in FIGS.10G-10H. Biasing mechanisms disposed between the slider plates 73 andthe cartridge 68 may also limit the outward motion of the slider plates73 as the needles are advanced therethrough. As further depicted in FIG.10I, when the suturing device 20 is disengaged and while the needles 34,36 are refracted, the surfaces of the cam slot 85 may abut the innerand/or outer edges of the needles 34, 36 in a manner configured tosecure the needle guide 62 within the needle recesses 74. Accordingly,it can be seen that the slider plates 73 enable the needles 34, 36 tosubstantially freely pass therethrough while conforming to the shape andmovement of the needles 34, 36 so as to ensure that each needle guide 62is securely held by the respective needles 34, 36 prior to and duringdeployment. It should be understood that the slider plates 73 may besimilarly adapted for antegrade configurations employing needles 34, 36with recesses 74 configured to engage with needles guides 62 uponadvancement rather than retraction.

Turning now to FIGS. 11A-11J, alternative embodiments for the suture 32which can be used in conjunction with the teachings of the presentdisclosure are disclosed. For example, while FIGS. 1-9 depict the suture32 with a smooth filament 56, FIGS. 11A-11F depict sutures 32 withmultiple tines 76 or other elements radially and outwardly extendingfrom the cylindrical filament 56. As will be noted, in some embodiments,the elements 76 all extend in the same direction, while in otherembodiments, they extend in opposite directions. The elements 76 may becanted in one direction to facilitate insertion in that direction, buthinder removal in the opposite direction. For example, the elements ortines 76, as depicted in FIGS. 11A-11F, may also be provided in thesubstantial shape of spheres, cones, pyramids, fins, or any other two-or three-dimensional structures having canted sides 78 adapted tofacilitate insertion of the suture 32 through the tissue of the skinwhile enabling the skin to cam thereagainst. Furthermore, the elementsor tines 76 may be formed using a combination of different shapes, forexample, as shown by the finned, cone-type retention elements 76 of FIG.11E. Not only do the tines 76 serve as frictional interference devicesto better grip the first and second sections of skin once installed, butgiven the orientation which the suture 32 ultimately assumes uponinsertion, the tines 76 can actually interlock so as to form an eventighter closure, and avoid retraction and medialization as will bedescribed in further detail herein. Moreover, as shown in FIGS. 12A-12B,such tines 76 prevent medialization and refraction. As used herein,retraction refers to the tines preventing reverse movement of the sutureout of the skin or away from the intersecting portion on the sutureafter installation and medialization refers to laterally inward slidingof the suture past a central portion of the suture after being installedin the closed helical configuration of FIG. 12A.

With particular reference to FIGS. 11G-11J, further alternativeembodiments for the suture 32 can be implemented in accordance with theteachings of the present disclosure. In contrast to the sutures 32 ofFIGS. 11A-11F in which tines 76 and/or canted elements 78 were disposedon the filament 56, the sutures 32 of FIGS. 11G-11J providesubstantially smooth filaments 56 and instead provide tines 76 and/orcanted elements 78 directly on the needle guides 62. As with previousembodiments, the sutures 32 of FIGS. 11G-11J are similarly configured tofacilitate insertion of the ends of the suture 32 in a correspondingdirection while hindering removal in an opposing direction. Morespecifically, each needle guide 62 may be configured to at leastpartially collapse upon insertion so as to minimize physical resistancewith the skin, but expandable when pulled in an opposing direction so asto maximize resistance and hinder removal thereof. Additionally oroptionally, each end of the suture 32 may have more than one needleguide 62 as shown in phantom lines in FIG. 11G so as to further hinderremoval from the skin once inserted. While the tip of each needle guide62 in FIG. 11G is rounded, alternative modifications may employ needleguides 62 with more canted or sharper tips to further facilitateinsertion thereof as depicted in FIGS. 11H-11J. Moreover, the needleguides 62 can generally be formed in the shape of a loop, circle,ellipse, oval, square, triangle, polygon, or any other suitable shapewhich at least marginally facilitates insertion thereof into skin buthinders removal. The needle guides 62 may additionally be formed as asimple thickening without an aperture that is sized and configured to beengaged by the recesses 74 of the first and second needles 34, 36 duringinsertion into the skin, as well as to prevent retraction from thetissue once deployed. Furthermore, with any of the foregoing types ofsutures, the device 20 may include a magazine (not shown) of sutures soas to advance each into successive position automatically afterinstallation of the preceding suture.

In operation, the suturing device 20 can be used to quickly andeffectively close an incision in human skin with precise alignment ofthe sections of skin to be closed, close approximation of the closureedges, and minimal scarring. With reference to FIGS. 13-14, first andsecond sections of skin 79, 80 are shown inserted into the first andsecond guide channels 82, 84 of a test fixture 86 constructed inaccordance with the teachings of this disclosure. Of course, forcomplete disclosure, it should be noted that FIGS. 13-14 are simply adepiction of a test version of the suturing device 20 completing aclosure in accordance with a sample of skin. In actual operation, anincision may be provided somewhere within the human body, and theoperating end 30 may be positioned under the skin relative to theincision such that the skin sections 79, 80 are received in the guideschannels 50, 52, and the sub-dermal side of the skin sections 79, 80 mayrest on the serrations 75 of the cartridge frame 71. In one of theseveral possible methods of using the suturing device 20, the suturingdevice 20 may initiate its operation at one end of the incision 89,install a suture 32, and then longitudinally retract along the closureuntil the next suture is inserted and so on. This process would continueuntil the incision is completely closed as depicted in FIGS. 15A-15E.Additionally, first and second restraining jaws 90, 92 may be providedwhich, when rotated upwardly, are configured to engage the sub-dermallayer 94 of the skin sections 79, 80. The restraining jaws 90, 92 may beomitted or added as an optional feature in certain embodiments, such asin the embodiment of FIGS. 1-9 which has serrations 75 configured toserve essentially the same purpose.

In an alternative method of use, for example, the suturing device 20 mayinitiate its operation and install a suture 32 substantially at themiddle of the incision 89 so as to segment the incision 89 into twohalves. Subsequent sutures 32 may be installed in a similar manner andpositioned so as to further segment each remaining half of the incision89 into two smaller halves, and so forth, until the incision 89 iscompletely closed. In a still further method, the suturing device 20 maybe used to install sutures 32 beginning at the ends of the incision 89until the sutures 32 meet at the middle to completely close the incision89. Further alternative methods of using the suturing device 20 will beapparent to those skilled in the art.

Still referring to FIGS. 13 and 14, when the trigger 26 of the suturingdevice 20 is compressed toward the handle 24, the first and secondarcuate needles 34, 36 rotate and thereby insert themselves through thedermal layer 94 of the first and second sections of skin 79, 80,respectively. In so doing, using a pair of needles 34, 36 as configuredin FIG. 9A, the suture 32 can be installed in a retrograde fashion inthat the first and second arcuate needles 34, 36 can be fully rotated,and then only after being fully rotated, will both needle guides 62 ofthe suture 32 be captured and, upon retraction of the needles 34, 36 andrelease of the suturing device 20, pulled through the respective skinsections 79, 80 in opposite directions. Conversely, using a pair ofneedles 34, 36 as configured in FIG. 9B, the suture 32 can be pushed inan antegrade manner by the needle guide 62 through the section of skinwhich it first enters, cross over interface 96 between the first andsecond sections of skin 79, 80 and into the second section of skin. Ineither the antegrade or the retrograde configuration, as both needles34, 36 are simultaneously moving and rotating substantially equaldistances, both needle guides 62 are being so pushed or pulled inopposing directions. In alternative embodiments, each needle 34, 36 maybe rotated substantially equal distances but at unequal rates of angulardisplacement.

Using either an antegrade or a retrograde suturing scheme, afterinstallation of the suture 32, the needles 34, 36 will have pierced bothsections of skin 79, 80, and the suture 32 will be transformed from aplanar, bi-planar, multi-planar, or any other non-helical configurationto a substantially helical configuration. Furthermore, using either oneof the antegrade or the retrograde configuration, the suturing device 20may be adapted to form a closed helix or an open helix simply byadjusting the starting position of the suture 32 relative to the needles34, 36. As shown in FIGS. 16A-16N, for example, a single suturing device20 used in the retrograde configuration can form both closed helix andopen helix closures using identical sutures 32 simply by adjusting thestarting position of the suture 32 placed thereon prior to engaging thesuturing device 20. Although not shown, a single suturing device 20 usedin the antegrade configuration can similarly be used to form both closedhelix and open helix closures using identical sutures 32 simply byadjusting the starting position of the suture 32 placed thereon prior toengaging the suturing device 20.

With particular reference to FIGS. 16A-16G, the retrograde suturingdevice 20 can be used to form closed helix closures by setting thesuture 32 in the starting position shown in FIG. 16A. In the startingposition shown, the suture 32 is positioned such that each needle guide62 thereof is adapted to receive its corresponding needle 34, 36 and beengaged by the recess 74 of the needle 34, 36 upon compression of thesuturing device 20. Moreover, in order to form a closed helix closure,the filament 56 of the suture 32 is routed around the outside of andbetween the needle tips 72, as shown in FIG. 16A. As the suturing device20 is engaged, each needle tip 72 may rotate toward its correspondingneedle guide 62, as shown in FIGS. 16B-16C, until the recesses 74 engageboth needle guides 62, as shown in FIGS. 16D-16F. Once each needle guide62 is engaged, release of the suturing device 20 may pull the needlesguides 62 through the skin in retrograde fashion until a closed helix ora closed helical knot-like configuration is formed, as shown in FIG.16G.

Turning now to FIGS. 16H-16N, the retrograde suturing device 20 can alsobe used to form open helix closures by setting the suture 32 in thestarting position shown in FIG. 16H. In the starting position shown, andsimilar to the closed helix starting position of FIG. 16A, the suture 32is positioned such that each needle guide 62 thereof is adapted toreceive its corresponding needle 34, 36 and be engaged by the recess 74of the needle 34, 36 upon compression of the suturing device 20. To forman open helix closure, the filament 56 of the suture 32 is routed awayfrom but still between each needle tip 72, as shown in FIG. 16H. As thesuturing device 20 is engaged, each needle tip 72 may rotate toward itscorresponding needle guide 62, as shown in FIGS. 16I-16K, until therecesses 74 engage both needle guides 62, as shown in FIGS. 16L-16M.Once each needle guide 62 is engaged, release of the suturing device 20may pull the needles guides 62 through the skin in retrograde fashionuntil an open helix configuration is formed, as shown in FIG. 16N.

The embodiments of FIGS. 17-18 depict similar open helical fastenerconfigurations that are inserted into exemplary wounds. For example,FIG. 17 shows the dermal layer 94 of the first and second sections ofskin 79, 80 after suture insertion with the filament 56 traversingthrough the first and second sections of skin 79, 80 and across theinterface 96, with the first and second ends 58 and 60 of the filament56 outwardly extending away from the dermal layer 94. The closure ofFIG. 18 is very similar to FIG. 17 but simply shows a plurality of suchsutures after installation. Perhaps most importantly, FIG. 19 shows theexterior or epidermal layer 88 of the first and second sections of skin79, 80 after suture insertion. As shown therein, the first and secondsections of skin 79, 80 are horizontally aligned such that the interface96 is linear and tightly grouped. In addition, the first and secondsections of skin 79, 80 are vertically aligned so as to be positionedwithin the same plane. This is effectively illustrated in a comparisonof FIGS. 20A-20C.

Starting with FIG. 20A, this shows a closure using manually placedsutures. As shown, the first and second sections of skin 79, 80 are bothvertically and horizontally aligned, which would result in a minimumlevel of scarring. However, as indicated above, such manual insertion istime-consuming, tedious, and exposes healthcare workers to diseasetransmission through needle-stick injuries. On the contrary, FIG. 20Cshows a prior art device which uses automatic insertion of absorbablestaples, but as shown, not only are the first and second sections ofskin not vertically and horizontally aligned, but result in asubstantial ridge 98 extending from the epidermal layer 88 which wouldform a significant scar on the patient. The resulting closure affordedby the teachings of the present disclosure, on the other hand, isdepicted in FIG. 20B. As shown therein, the interface 96 is horizontallyand vertically aligned and tightly grouped. In addition, a minimum ofscarring will result given this close vertical and horizontalapproximation, thus avoiding the unsightly scarring of the prior artdevice of FIG. 20C. Moreover, as the suturing is performedsemi-automatically by the suturing device 20 of the present disclosure,the substantial time commitment required by manual placement of suturesof FIG. 20A is avoided.

Accordingly, a retrograde application of a suture 32 can result ineither a closed helix or an open helix configuration depending on themanner in which the suture 32 is set in the starting position and priorto deployment. Although only retrograde applications of both closed andopen helix sutures are depicted, it can be seen that an antegradeapplication of a suture 32 can similarly be used to provide either aclosed helix or an open helix suture depending on the manner in whichthe suture 32 is set in the starting position and prior to deployment.

Referring now to FIGS. 21-27, an alternative embodiment of a suturingtool that can be used against the epidermal layer of the skin isdisclosed. In other words, rather than be inserted into an incision suchthat the needles drive upwardly into the sub-dermal and dermal layers ofthe skin as with the first embodiment, the alternative embodiment ofFIGS. 21-27 is adapted to rest against the outside or epidermal layer ofthe skin and install sutures downwardly into the epidermal and dermallayers of the skin. As all other features of the alternative embodimentare similar, rather than walk through each element herein, the readerwill note the like elements use like reference numerals as with thefirst embodiment but for the inclusion of a “100” series prefix.

Turning to FIG. 28, an alternative embodiment of a drive mechanism 228for a suturing tool is disclosed. For example, the drive mechanism 228shown may be used with the test fixture 86 of FIGS. 13-14 so as toprovide yet another way to rotate the needles 234, 236 in oppositedirections. More specifically, the drive mechanism 228 may includecoaxial drive shafts 248, 249, where each coaxial drive shaft 248, 249is coupled to a corresponding needle 236, 234. Each coaxial drive shaft248, 249 is further coupled to a corresponding gear 246, 247 such that arotation of the gears 246, 247 also causes a corresponding rotation ofthe needles 236, 234. Moreover, the first gear 246 may be driven by thefirst gear rack 241, while the second gear 247 may be independentlydriven by a second gear rack 242, which although not shown in FIG. 28for illustrative purposes, may substantially mirror the first gear rack241. In the configuration shown, when the gear racks 241, 242 are pushedin a downward direction, the gears 246, 247 are caused to rotate inopposing directions. As the gears 246, 247 rotate, the coaxial driveshafts 248, 249, and thus, the corresponding needles 236, 234 are alsocaused to rotate in opposing directions so as to install sutures 32 inaccordance with the teachings of the present disclosure.

The illustration of FIGS. 29-31 depicts still a further embodiment ofthe present disclosure. In such an embodiment, the suturing tool 300 canbe used laparoscopically. In other words, rather than being used on thedermal layer of the skin or even epidermal or sub-dermal, the tool 300enables sutures to be placed deep within the body cavity. This enablesrelatively small access port incisions to be made in the skin throughwhich the tool 300 can then be inserted to access the organ, muscularstructure or other tissue needing to be sutured. To facilitate suchusage, it will be noted that the tool 300 includes an elongated driveshaft 302 that extends from a handle 304 and actuating trigger 306.Similar to the other embodiments, actuation of the trigger 306 causesthe needles 308 and 310 to rotate. A shroud 312 surrounds the needles308 and 310. Such a laparoscopic tool 300 would be used in conjunctionwith a camera or other navigational tool to enable the needles to bemoved to the exact location within the body needing the sutures. Fromthe foregoing, it can be seen that in addition to incision closuremarket, the teachings of the present disclosure are well suited tolaparoscopic and minimally invasive applications. For example, thedisclosed fastener technology could be used to fasten prosthetic meshduring laparoscopic hernia repairs. The trend toward more minimallyinvasive operations will continue to present opportunities for thefastening technology disclosed herein.

From the foregoing, it can be seen that the present disclosure setsforth a medical device adapted to rapidly and reliably install suturesto close openings provided within human skin. The device not onlygreatly reduces the time required for placement of sutures compared tomanual suturing, but also results in highly accurate positioning of thefirst and second sections of skin along both the horizontal and verticalaxes to thus avoid substantial scarring after the healing process.Moreover, through the unique combination of elements set forth in thesuturing device, the first and second sections of skin are tightly heldtogether during the healing process to both increase the speed in thehealing process and minimize any resulting scarring.

What is claimed is:
 1. A suturing device, comprising: a first arcuateneedle adapted to rotate in a first direction through a dermal layer ofa first section of tissue to be sutured and through the dermal layer ofa second section of tissue to be sutured; a second arcuate needleadapted to rotate in a second direction opposite to the first rotationaldirection and through a dermal layer of a second section of tissue to besutured and through the dermal layer of the first section of tissue tobe sutured; and a drive mechanism forcing rotation of the first andsecond arcuate needles upon activation by a user from a pre-insertionposition to an engaged position and adapted to insert a suturedetachably attached to the first and second arcuate needles, the drivemechanism adapted to retract the first and second arcuate needles fromthe engaged position to the pre-insertion position to release the suturefrom the first and second arcuate needles.
 2. The suturing device ofclaim 1, further including a cartridge disposed within the suturingdevice, the cartridge containing one or more sutures being held withinthe cartridge.
 3. The suturing device of claim 2, wherein the suture istransformable from a first shape to a second shape, the first shapebeing within at least one plane, the second shape being one of an openhelix and a closed helix.
 4. The suturing device of claim 1, furtherincluding first and second guide channels disposed at an operating endof the drive mechanism and a septum blade positioned between the firstand second guide channels.
 5. The suturing device of claim 1, whereinthe drive mechanism is adapted to push the suture through the first andsecond sections of tissue as the first and second arcuate needles areadvanced in an antegrade configuration.
 6. The suturing device of claim1, wherein the drive mechanism is adapted to pull the suture through thefirst and second sections of tissue as the first and second arcuateneedles are retracted in a retrograde configuration.
 7. The suturingdevice of claim 1, wherein the first and second arcuate needles rotateat identical and symmetrical rates of angular displacement.
 8. Thesuturing device of claim 1, wherein the first and second arcuate needlesand the drive mechanism are configured to penetrate through asuperficial surface of the tissue.
 9. The suturing device of claim 1,wherein the first and second arcuate needles and the drive mechanism areadapted to suture.